Gilead Sciences, Inc. (Nasdaq:GILD) today announced the completion
of a Phase II clinical trial of GS 9137, a novel oral HIV integrase
inhibitor. The clinical study met its primary endpoint of
non-inferiority in viral load reduction in HIV-positive patients
receiving 50 mg or 125 mg of GS 9137 once daily, each boosted with 100
mg of ritonavir, in combination with an optimized background
antiretroviral regimen compared to a boosted comparator protease
inhibitor regimen (p=0.02 for the 125 mg arm).
This ongoing Phase II study is a partially-blinded, randomized,
active-controlled, 48-week clinical trial to evaluate the
non-inferiority of once-daily GS 9137 versus boosted comparator
protease inhibitors (CPI/r) in highly treatment-experienced
HIV-infected patients. After week eight, the GS 9137 20 mg arm was
closed due to a high rate of virologic failure. At this time, the
addition of darunavir or tipranavir to the GS 9137 study arms was
permitted, following the availability of data demonstrating a lack of
drug interactions between both protease inhibitors and GS 9137. The
primary endpoint of the study was DAVG24, a measure of viral load
reduction over 24 weeks.
Integrase inhibitors are an investigational class of
antiretrovirals that interfere with HIV replication by blocking the
ability of the virus to integrate into the genetic material of human
cells. Novel classes of HIV-fighting drugs are needed as patients live
longer and exhaust currently available treatment options.
About GS 9137
GS 9137, also known as JTK-303, was licensed by Gilead from Japan
Tobacco Inc. (JT) in March 2005. Under the terms of the company's
agreement with JT, Gilead has exclusive rights to develop and
commercialize GS 9137 in all countries of the world, excluding Japan
where JT retains rights. As an investigational compound, GS 9137 has
not yet been determined safe or efficacious in humans for its ultimate
intended use.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of unmet
medical need. The company's mission is to advance the care of patients
suffering from life-threatening diseases worldwide. Headquartered in
Foster City, California, Gilead has operations in North America,
Europe and Australia.
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, that
are subject to risks, uncertainties and other factors, including risks
related to Gilead's ability to successfully develop and commercialize
GS 9137. For example, the safety and efficacy data from additional
clinical studies may not warrant further development of this compound,
and initiating and completing clinical trials may take longer or cost
more than expected. Future discussions with the FDA may impact the
amount of data needed and timelines for review, and Gilead's clinical
trial protocol design, clinical endpoint and statistical analyses for
any additional trials will be subject to FDA review and approval. In
addition, integrase inhibitors represent a relatively new class of
compounds that has not had a long history of clinical research and
development. Therefore, Gilead may face challenges in clinical trial
protocol design and trial enrollment, and the results of clinical
trials involving integrase inhibitors may be less predictable than
with other drug candidates for the treatment of HIV. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements.
The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in the
Gilead's Annual Report on Form 10-K for the year ended December 31,
2005 and Reports on Form 10-Q for the first three quarters of 2006,
filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
For more information on Gilead Sciences, please visit the
company's website at www.gilead.com or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
